In adults with venous thromboembolism (VTE), treatment with direct oral anticoagulants (DOACs) is not associated with an increased risk of major bleeding or all-cause mortality within the first 90 days compared with warfarin, according to a study published in the BMJ.
Researchers conducted a retrospective matched cohort study using healthcare data from 6 jurisdictions in Canada and the United States to determine the safety of DOAC use compared with warfarin use for the treatment of VTE. The study included 12,489 DOAC users and 47,046 warfarin users with a new diagnosis of VTE and a prescription for a DOAC or warfarin within 30 days of the diagnosis.
The results showed that 3.3% of the study participants had a major bleed and 1.7% died during a mean follow-up of 85.2 days. The risk of major bleeding within 90 days was similar among patients receiving DOACs and those receiving warfarin (pooled hazard ratio [HR], 0.92), although the direction of the association favored DOACs.
In addition, the investigators observed no difference in the risk of all-cause mortality between the two treatment groups (HR, 0.99). They found no evidence of heterogeneity for the risk of major bleeding and the risk of all-cause mortality when patients were assessed according to chronic kidney disease status, age, and sex.
“Although we did not observe a lower risk of major bleeding with DOAC treatment in our study, given the absence of an increased bleeding risk and the advantages associated with its use particularly around frequency of monitoring and dosing, our results suggest that DOACs may be considered as a treatment option for patients with venous thromboembolism who are candidates for anticoagulation,” the authors noted.
Jun M, Lix LM, Durand M, et al. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study [published online October 17, 2017]. BMJ. doi:10.1136/bmj.j4323